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Following Endoscopic Care for Suspected Pancreatic and Bile Duct Tumors in Lombardy

Observes how endoscopic ultrasound is used in adults with suspected pancreatic tumors.

Plain-language title generated from the registry record
Registry title: Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units

Key facts

Where
Bergamo, Brescia, Cremona, Legnano, Mantua, Milan, Monza, Pavia, and Varese, ItalySee the 13 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who may have a tumour of the pancreas or of the area where the bile duct meets the bowel, and who are due to have an endoscopic ultrasound (EUS) as part of normal care.

Age
18 years or older
Sex
All sexes can join
Disease stage
Suspected pancreatic tumour (adenocarcinoma, neuroendocrine tumour, or cystic tumour needing endoscopic, surgical or cancer treatment) or suspected periampullary tumour (distal bile duct, ampulla, duodenum)

Main reasons for not taking part

  • Under 18 years old
  • Pregnant or breastfeeding
  • Conditions other than those listed for joining
  • Cannot give informed consent
  • Refuses to take part

Read by machine on 13 November 2026.

Where in Italy

  • ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII BergamoBergamo, ItalyContact: Salvatore GrecoNo longer taking part
  • ASST Spedali Civili di Brescia - P.O. Spedali Civili BresciaBrescia, ItalyContact: Gianpaolo CengiaNo longer taking part
  • Casa di Cura Poliambulanza di BresciaBrescia, ItalyContact: Paolo CesaroNo longer taking part
  • ASST di Cremona - P.O. CremonaCremona, ItalyContact: Roberto GrassiaNo longer taking part
  • ASST Ovest Milanese - P.O. LegnanoLegnano, ItalyContact: Pietro GiambittaNo longer taking part
  • ASST Mantova - P.O. Carlo Poma MantovaMantua, ItalyContact: Nicola MantovaniNo longer taking part
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Massimiliano MutignaniNo longer taking part
  • ASST Santi Paolo e Carlo - MilanoMilan, ItalyContact: Gaetano Lauri, PhDsNo longer taking part
  • Fondazione IRCCS - Istituto Nazionale dei Tumori - MilanoMilan, ItalyContact: Paolo CantùNo longer taking part
  • IRCCS Istituto Clinico Humanitas MilanoMilan, ItalyContact: Alessandro RepiciNo longer taking part
  • Fondazione IRCCS San Gerardo dei Tintori - MonzaMonza, ItalyContact: Marco DinelliNo longer taking part
  • Fondazione IRCCS Policlinico San Matteo PaviaPavia, ItalyContact: Andrea AnderloniNo longer taking part
  • ASST Sette Laghi - Ospedale di Circolo e Fond. Macchi VareseVarese, ItalyContact: Sergio SegatoNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
IRCCS San Raffaele
Trial code
NCT07418164
Record updated
3 September 2026
Original description
The GENTLENESS study is a prospective, multicenter, observational registry designed to evaluate the endoscopic management of patients with suspected biliopancreatic and periampullary neoplastic diseases within the Pancreas Units network of the Lombardy Region.Read full original descriptionShow less

Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study

The GENTLENESS study is a prospective, multicenter, observational registry designed to evaluate the endoscopic management of patients with suspected biliopancreatic and periampullary neoplastic diseases within the Pancreas Units network of the Lombardy Region.

Patients undergoing endoscopic ultrasound (EUS) for suspected pancreatic or periampullary malignancies, including pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, cystic pancreatic neoplasms requiring endoscopic, surgical, or oncological management, and periampullary tumors of the distal bile duct, ampulla, or duodenum, will be prospectively enrolled according to standard clinical practice.

The study aims to assess the diagnostic accuracy of EUS-guided tissue acquisition, procedural safety, the need for repeat sampling, and organizational performance indicators, including time to definitive cyto-histological diagnosis and time to initiation of disease-specific treatment. No additional procedures beyond routine clinical care will be performed as a result of study participation.

Inclusion: Adults (≥18 years); Clinical, biochemical, and/or imaging suspicion of pancreatic neoplasia (adenocarcinoma, neuroendocrine tumors, cystic neoplasms requiring endoscopic, surgical, or oncological treatment) or periampullary neoplasia (distal bile duct, ampulla, duodenum); Candidate for EUS according to standard clinical practice; Ability to understand and sign informed consent.

Exclusion: Conditions other than those defined in the inclusion criteria; Age <18 years; Pregnancy or breastfeeding; Inability to provide informed consent; Refusal to participate in the study.

ClinicalTrials.gov NCT07418164